Lead and Internal Auditor Training

Gain the confidence to run effective audits in our popular ISO 13485 lead and internal auditor training classes, and our new Internal Auditing to MDSAP class. These courses consistently earn high marks (an average of 6.7 out of 7) because they are is interactive and yield a solid understanding of the relevant standard, every audit phase, and how to implement the standard within an organization.

Which Auditor Course Is Right for You?

Our ISO 13845 lead auditor class prepares you to conduct and lead quality management system (QMS) audits for medical devices through simulations, exercises, and workshops – all of which have been updated to use ISO 13485:2016 criteria. Our approach teaches the audit discipline in accordance with ISO 19011 while providing a sector-focused learning experience for those engaged in the medical device industry. This course is certified by Exemplar Global and satisfies the training requirements for individuals pursuing certification as QMS Lead Auditors.

Our ISO 13485 internal auditor classprepares you to develop, implement, and perform internal audits of a quality system that efficiently and effectively meets the requirements of ISO 13485 and ISO 9001. This course is certified by Exemplar Global.

Designed for experienced auditors, our new Internal Auditing to MDSAP class is the only MDSAP auditing class that can help you earn an Exemplar Global certification for QM-MDSAP Competency demonstrating knowledge and ability to conduct MDSAP audits.

Public and On-Site Training Options

Our ISO 13485 lead auditor training classes – as well as our other auditing classes – are offered frequently in 12 cities across the US and Costa Rica. All of our classes can also be delivered as private, on-site training programs tailored specifically for your company. On-site training tends to be a more cost-effective alternative for groups of five or more.

Materials Licensing

Oriel STAT A MATRIX’s training materials provide the foundation for the performance improvement and regulatory compliance training programs of scores of organizations – including many Fortune 500 companies. We offer comprehensive support tools (including detailed instructor guides) to ensure a consistent training experience throughout the organization.

Exemplar Global Certified

Exemplar Global certification demonstrates a level of rigor and industry-recognized quality for the course. Oriel STAT A MATRIX’s Exemplar Global Certified auditor courses provide the necessary body of knowledge for individuals to pursue Exemplar Global certification under the “qualification-based” or “competency-based” auditor schemes.

Unique to MDSAP audits are a process-based audit approach and use of a nonconformity grading matrix. Understanding these two critical components of MDSAP is key to a successful certification audit, and this course covers both in depth. Click to learn more.

Designed for experienced auditors, this intensive class will teach you how to apply MDASP's process-based audit approach and align your current internal audit program to the MDSAP requirements. Click to learn more.